1. Field of the Invention
The present invention relates generally to processing and disinfecting human blood products. More particularly, this invention relates to disinfecting whole blood, blood cells, plasma proteins, and plasma so that they may be used safely and effectively for diagnostic, therapeutic or research purposes. 2. Description of the Related Art
Blood products from human and animal donors are widely used for therapeutic, diagnostic and experimental purposes. A persistent problem associated with using blood products from human and animal donors is that these products are subject to contamination by blood-borne viruses and other micro-organisms such as bacteria.
Of particular threat are viruses that appear to cause various forms of hepatitis, including the hepatitis B virus; the non-A, non-B hepatitis virus or viruses. Others of interest are cytomegalovirus and Epstein-Barr virus.
Viruses linked with the incurable and often fatal disease known as acquired immune deficiency syndrome or "AIDS" are probably caused by a retrovirus or group of retroviruses previously denominated "HTLV-III" and other HTLV types--and more currently "HIV" "HIV-1" and "HIV-2." The most common cause of AIDS is thought to be HTLV-III, now usually called HIV-1.
Detection and isolation of such cytopathic retroviruses from patients with AIDS, and certain members of groups that are at high risk for AIDS, have been frequently reported. One such report appears in Science 224:500-03 (1984). Such findings are corroborated by P. S. Savin, et al., in an article entitled "Human T-Lymphotrophic Retroviruses in Adult T-cell Leukemia-Lymphoma and Acquired Immune Deficiency Syndrome," J. Clinical Immunol. 4:415-23 (1984). Yet another report is by F. Wong-Staal and R. C. Gallo, "Human T-Lymphotrophic Retroviruses," Nature 317:395-402 (1985).
The threat of hepatitis, AIDS, and bacterial transmission through transfusion and administration of blood products is not limited to blood cells but extends to the administration of plasma and plasma fractions such as Factor VIII concentrates, Factor IX concentrates, gamma globulin, and antithrombin III.
Disinfecting whole blood and blood products, including red blood cells, plasma, and plasma fractions with disinfectants strong enough to significantly inactivate viruses, bacteria and other organisms has generally been discounted because they have been believed to damage cellular blood constituents or inactivate plasma and plasma protein factions. Additionally, the presence of any residual disinfectant in the blood product to be transfused could be hazardous to the recipient of the transfusion.
One disinfectant in use for blood products is beta-propiolactone. Beta-propiolactone, however, is a known carcinogen and hence potentially very dangerous. To the extent that significant residual amounts of this material may remain in the blood product which is actually transfused, the use of propiolactone represents a potential hazard.
U.S. Pat. No. 4,833,165 relates to using as little as 0.1% formaldehyde and/or phenol to inactivate HTLV-III in blood. However, recently available data and information indicate that red blood cells treated with as little as 0.02% formaldehyde and 0.01% phenol are not viable and not suitable for transfusion.
Applicant's former applications disclose the utility of normal saline and other isotonic solutions of chlorine dioxide for sterilizing certain blood products and tissue products. Quite unexpectedly, chlorine dioxide, a disinfectant strong enough to inactivate blood born viruses and microorganisms, can be utilized to disinfect cellular blood products without destroying the vitality and integrity of the cells.
There is a continuing need to provide systems for disinfecting blood products. In particular, there is a need to disinfect human and animal plasmas fractions so that they can be safely and effectively utilized by a recipient or handled by a user without exposure to harmful viruses and micro-organisms.